天津中医药2018，Vol.35Issue(5)：324-328,5.DOI:10.11656/j.issn.1672-1519.2018.05.02
宝儿康散剂量加倍治疗小儿慢性迁延性腹泻病脾虚湿困证评价其有效性和安全性的随机双盲、阳性药和原剂量平行对照、多中心临床试验
钟成梁 1全惜春 2苏保玲 3杜永刚 4刘玉凤 5马斯风 6洪丽军 7邵荣昌 8王爱珍 9李学明 10胡思源 1郭圣璇 11李新民 1韩选明 12谢晓丽 13潘树强 14徐桂萍 15湛治萍16
作者信息
- 1. 天津中医药大学第一附属医院,天津300193
- 2. 南阳市中医院,南阳473000
- 3. 长治医学院附属和济医院,长治046000
- 4. 长治市人民医院,长治046000
- 5. 辽宁中医药大学附属第四医院,沈阳110000
- 6. 大庆市中医医院,大庆163000
- 7. 牡丹江市中医医院,牡丹江157000
- 8. 鄂州市中心医院,鄂州436000
- 9. 泰州市中医院,泰州225300
- 10. 邯郸市中医院,邯郸056000
- 11. 天津中医药大学,天津300193
- 12. 陕西中医药大学第二附属医院,咸阳712000
- 13. 成都市妇女儿童中心医院,成都610000
- 14. 钦州市妇幼保健院,钦州535000
- 15. 惠州市中医医院,惠州516000
- 16. 贵州省黔南布衣族苗族自治州中医医院,黔南州558000
- 折叠
摘要
Abstract
[Objective]To evaluatethetherapeutic effect of Baoerkang powder of different doses on chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children, as well as shortening the course and improvement of traditional Chinese medicine syndrome, while observing the safety of clinical applications. [Methods]A randomized, double-blind, double-dummy,parallel,active-controlled and multi-center clinical research method was adopted. The 168 patients of 15 centers were enrolled and randomly separated into double dose group,original dose group and control group(Zhixieling granules)in the rate of 1:1:1. Treatment course lasted for 5 days.Diarrhea efficacy,traditional Chinese medicine syndrome efficacy,antidiarrheal time,single symptom efficacy were observed.And the security was evaluated. [Results]The total effective rate of diarrhea was 89.29% in the double dose group,69.09% in the original dose group and 65.45% in the control group.There was statistical difference amongthe three groups.The double dose group was superior to the original dose group and the control group.the median antidiarrheal time were 4 days,5 days and 5 days in double dose group, low dose group and control group,respectively. Double dose group recover faster, and there is significant difference between them.The total effective rate of traditional Chinese medicine syndrome efficacy was 94.64% in the double dose group, 89.09% in the original dose group and 81.82% in the control group.There was statistical difference among the three groups.The double dose group was superior to the control group,and the same for single symptoms,such as thin sloppy stool and increased stool frequency. During the study,there were 1 case(1.79%)adverse event in the original dose group.The researchers determined that it had nothing to do with the experimental medication. [Conclusion]Baoerkang powder in double dose that has the effect of improving the symptoms of diarrhea,shortening the course and improving traditional Chinese medicine syndrome was superior to the control dose group(Zhixieling granules)and the original group(the dosage of instructions)on treating chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children,and has good safety.关键词
宝儿康散/止泻灵颗粒/随机对照试验/小儿迁延性和慢性腹泻病Key words
Baoerkang powder/Zhixieling granule/RCT/children with chronic persistent diarrhea disease分类
医药卫生引用本文复制引用
钟成梁,全惜春,苏保玲,杜永刚,刘玉凤,马斯风,洪丽军,邵荣昌,王爱珍,李学明,胡思源,郭圣璇,李新民,韩选明,谢晓丽,潘树强,徐桂萍,湛治萍..宝儿康散剂量加倍治疗小儿慢性迁延性腹泻病脾虚湿困证评价其有效性和安全性的随机双盲、阳性药和原剂量平行对照、多中心临床试验[J].天津中医药,2018,35(5):324-328,5.
